EUCTR2020-004335-24-BE进行中（未招募）1 期
A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 269
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 a. Subject must have participated in Study CC-93538-EE-001, and meets one of the following criteria:
- •1) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
- •2) Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
- •3) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
- •4) Subject completed Week 48 of the Maintenance Phase b. OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments in Period 2 through Week 18/End of Treatment Visit.
- •2. Demonstrated compliance with required investigational product dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI-001 and subject must not have been permanently discontinued from IP while participating in Study CC-93538-EE-001 or Study CC-93538-DDI-001.
- •3. Subjects must have not experienced any clinically significant adverse events related to Investigational Product that would preclude further dosing.
- •4. Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.
- •5. Subject (18 years of age or older) must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF (called a Transitional ICF) themselves to acknowledge their willingness to continue in the study. In Austria, Germany, Spain, and Switzerland, adolescent subjects will not be enrolled.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 19
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
- •2. Subject demonstrates presence of esophageal varices.
- •3. Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition
- •4. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
- •5. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
- •6. Received an investigational product, other than that administered in CC-93538-EE-001 or Study CC-93538-DDI-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 or Study CC93538-DDI-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician.
- •7. Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
- •8. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, a documented medical diagnosis of gastritis, which is clinically significant in the judgment of the Investigator; colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE).
- •9. Active or ongoing infections including parasitic/helminthic infections
- •10. Subject has a chronic infection (eg, hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical
- •guidelines).
- •11. Females who are pregnant or lactating
研究者
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